ISO 11616:2012 pdf download.Health informatics — ldentification of medicinal products -Data elements and structures for unique identification and exchange of regulated pharmaceutical product information.
3.1.15
investigational medicinal product
pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form
3.1.16
Jurisdiction
geographical area or subject matter to which the pharmaceutical legislative authority applies
3.1.17
manufactured dose form
pharmaceutical dose form as presented in the packaging by the manufacturer, before any necessary transformation has been carried out to yield the administered dose form
EXAMPLE Powder fo solution for injection.
NOTE In many instances, there is no transformation necessary and the manufactured dose form is equal to the administered dose form.
3.1.18
medical device
any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
— investigation, replacement or modification of the anatomy or of a physiological process;
— control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological o metabolic means, but which may be assisted in its function by such means.
investigational medicinal product
pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form
3.1.16
Jurisdiction
geographical area or subject matter to which the pharmaceutical legislative authority applies
3.1.17
manufactured dose form
pharmaceutical dose form as presented in the packaging by the manufacturer, before any necessary transformation has been carried out to yield the administered dose form
EXAMPLE Powder fo solution for injection.
NOTE In many instances, there is no transformation necessary and the manufactured dose form is equal to the administered dose form.
3.1.18
medical device
any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
— investigation, replacement or modification of the anatomy or of a physiological process;
— control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological o metabolic means, but which may be assisted in its function by such means.
